Excluded Subject Matter (9) – Biotechnological inventions

"Biotechnological inventions" are inventions that concern biological material or a process by means of which biological material is produced, processed or used. In principle, biotechnological inventions are patentable under the European Patent Convention (EPC), but there are areas of excluded subject matter to navigate. 

Namely, the EPC prohibits the grant of patents to "plant or animal varieties or essentially biological processes for the production of plants or animals", but that "this provision shall not apply to microbiological processes or the products thereof". The Implementing Regulations and case law of the EPO has further interpreted this to exclude "plants or animals exclusively obtained by means of an essentially biological process". 

In relation to biological material of human origin, the Implementing Regulations state that "the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions". However, "an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element". 

The EPO also prohibits patents for inventions that are considered contrary to morality, which can apply to biotechnological inventions that concern (a) processes for cloning human beings;  (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. 

Taking the above exclusions into account, the following biotechnological inventions may therefore be patentable at the EPO: 

• Biological material which is isolated from its natural environment or produced by means of a technical process, even if it previously occurred in nature.
• Plants or animals, if the technical feasibility of the invention is not confined to a particular plant or animal variety, and if said plants or animals are not exclusively obtained by means of an essentially biological process.
• A microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety. 

Biological material

The EPO's approach to patenting biological material is particularly noteworthy in that it is more permissive than the approach taken in the USA. 

At the EPO, a biological element isolated from the human body may be patentable if it is produced by means of a technical process, even if the biological element previously occurred in nature. This technical process could be for example means to identify, purify and classify the biological element or to produce it outside the human body; which are techniques that human beings alone are capable of putting into practice and which nature is incapable of accomplishing itself. 

In contrast, since 2012 the US Supreme Court has made many biotechnological inventions ineligible for patent protection for being "natural phenomena" and "effectively claiming the underlying laws of nature". For example, in Ariosa v Sequenom, the US Court of Appeals for Federal Circuit found Sequenom's diagnostic patents invalid for relating to ineligible natural phenomena. Claim 1 of Sequenom's patent was to "A fraction of a sample of the blood plasma or serum of a pregnant woman in which, as the result of said sample having been submitted to a DNA extraction, followed by a size separation, of the extracellular DNA, the extracellular DNA present therein substantially consists of DNA consisting of 500 base pairs or less." Maternal blood and its contents were considered naturally occurring phenomena that were ineligible for patent protection. 

At the EPO, Sequenom's patent was opposed for lack of novelty and inventive step, insufficiency and added subject matter, but excluded subject matter as a naturally occurring phenomena was not run as an argument. The EPO's Opposition Division found the claim patentable on the basis that "DNA consisting of 500 base pairs or less" was a definite technical feature limiting the claimed product and provided a novel size fraction as a result of a method of size separation on maternal blood. The biological element was thus isolated from the human body and produced by means of a technical process. The novel size fraction was found inventive for detecting fetal generic traits in maternal blood plasma DNA. 

Conclusion

In principle, biotechnological inventions are patentable in Europe; in many cases where similar protection might not be available in the USA. However, there are still complex exclusions from patentability that will need to be considered carefully. 

This article is a part of our EPO Practice and Peculiarities series. Click here to explore.